West Medical Supplies – FDA Inspection, May 26, 2026

Record Details

This FDA Inspection record concerns West Medical Supplies, with an inspection on May 26, 2026, issued by the Florida District Office, covering medical devices & rad health.

Company: West Medical Supplies
Inspection Date: May 26, 2026
Product Type: Medical Devices & Rad Health
Office: Florida District Office
Person: Ebony D. Sanon (Issuing Officer)

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ID · a70605bf-346c-4696-ab3e-da635cd32736

Inspection Facts

Inspection number: 1319030
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 4.2.1Quality management system documentation not adequate
ISO 13485:2016 Clause 4.2.4Lack of document control
ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented

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FDA Inspection

West Medical SuppliesMay 26, 2026